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Cell Therapy Manufacturing

Fully integrated CDMO support throughout the entire product lifecycle.
center for breakthrough medicines cell therapy team member

World-class capabilities delivering capacity to patients waiting for treatments

While cell therapies continue to advance at a rapid pace, capacity to produce these life-saving therapies has been challenged leading to eligible patients succumbing to disease while on the waitlist for treatment. Center for Breakthrough Medicines (CBM) is a CDMO dedicated to bringing capabilities to the full cell therapy manufacturing process from early development to large-scale commercial production to eliminate existing bottlenecks, so patients get the treatment they need. Our team has unparalleled prior experience in advancing cell therapies to IND and all the way to commercialization, and our clients can leverage our large single source facility, capable of fully integrated production, with flexible, forward-engineered suites and client-centric program management.

Integrated capabilities to accelerate the development of autologous and allogeneic therapies

CBM offers end to end capabilities for autologous and allogeneic cell therapies including process development, analytical development & testing services and cGMP manufacturing. Our single source integrated services simplifies management of programs and supports rapid advancement to clinical trials and commercial production CBM has the expertise and production agility to keep your project moving, as well as crucial knowledge of the regulatory environment. CBM can either develop and optimize client-specific processes or tech transfer in established processes.
allogenic cell therapy manufacturing cell rendering

GMP workflows and equipment support a range of cell therapies

Viral & Non-Viral Gene-Mediated

World-class processes and production platforms

For autologous cell therapy products, we employ sophisticated scheduling, supply chain and inventory control systems aligned with in-process testing, quality control, and lot release programs to overcome manufacturing challenges. A structured process ensures integrity through Chain of Identity and Chain of Custody from receipt of donor/patient material to processing, storage, and shipment back to the Authorized Treatment Centers.

For allogeneic cell therapy products, well-characterized cell banks may be scaled up with suspension systems using single-use bioreactors from 20L to 500L to meet clinical and commercial demand for the cell products.

The manufacture of the final material is based on the drug product process, determined by route of administration, target tissue, clinical protocol, and patient population. World-class Manufacturing Execution and Quality systems minimize manufacturing hiccups while streamlining efficiency enabling parallel batch processing and reducing manual data entry and review times by 50-70%. This translates to

  • 40% reduction in OPEX per cleanroom for our clients
  • 30-40 additional manufacturing days saved for incremental dose capacity

Cell-Derived Therapies

  • CAR-T Cells
  • TCR
  • Dendritic Cell & NK Cell
  • TILs
  • Treg

Tissue-Derived Therapies

  • iPSC
  • Mesenchymal Stem Cells
  • Hematopoietic Stem Cells

CBM supports clients with agile, flexible cell therapy capabilities

Technologies for open & closed systems
Range of production scales
Clinical manufacturing
Commercial manufacturing

Rapid development and full program transparency

Our process development team begins by transferring in knowledge from our client, followed by work to ensure a robust and scalable process. CBM's platform enables clients to reduce the development timeline and deliver for patients sooner. We map the entire journey of your product from early development to commercialization, building in the requisite milestones to track progress and ensure quality all the way down the path. We are fully transparent in our partnerships, with an experienced program management team giving you clear oversight of your project through regular updates, on-site access, and the potential for dedicated office space with our Partner-in-Plant program.

Our quality control (QC) team operates in direct conjunction with manufacturing for method transfer, optimization, qualification, and validation. The labs are directly adjacent to production for rapid and seamless cGMP testing. Core cell therapy methods include:

  • qPCR, rapid micro methods, flow cytometry, ELISA, and automated cell counting.
  • Incoming raw material, in-process and final product testing.
  • Network of qualified contract testing laboratories to supplement in-house capabilities.
  • Environmental, personnel and utility monitoring.
center for breakthrough medicines cell therapy manufacturing OPCAL equipment